Chappell, FM, Crawford, F, Horne, M, Leese, GP, Martin, A, Weller, D, Boulton, AJM, Abbott, C, Monteiro-Soares, M, Veves, A and Riley, RD (2021) Development and validation of a clinical prediction rule for development of diabetic foot ulceration: an analysis of data from five cohort studies. BMJ Open Diabetes Research and Care, 9 (1). pp. 1-18. ISSN 2052-4897

[thumbnail of e002150.full.pdf]
e002150.full.pdf - Published Version
Available under License Creative Commons Attribution Non-commercial.

Download (631kB) | Preview


INTRODUCTION: The aim of the study was to develop and validate a clinical prediction rule (CPR) for foot ulceration in people with diabetes. RESEARCH DESIGN AND METHODS: Development of a CPR using individual participant data from four international cohort studies identified by systematic review, with validation in a fifth study. Development cohorts were from primary and secondary care foot clinics in Europe and the USA (n=8255, adults over 18 years old, with diabetes, ulcer free at recruitment). Using data from monofilament testing, presence/absence of pulses, and participant history of previous ulcer and/or amputation, we developed a simple CPR to predict who will develop a foot ulcer within 2 years of initial assessment and validated it in a fifth study (n=3324). The CPR's performance was assessed with C-statistics, calibration slopes, calibration-in-the-large, and a net benefit analysis. RESULTS: CPR scores of 0, 1, 2, 3, and 4 had a risk of ulcer within 2 years of 2.4% (95% CI 1.5% to 3.9%), 6.0% (95% CI 3.5% to 9.5%), 14.0% (95% CI 8.5% to 21.3%), 29.2% (95% CI 19.2% to 41.0%), and 51.1% (95% CI 37.9% to 64.1%), respectively. In the validation dataset, calibration-in-the-large was -0.374 (95% CI -0.561 to -0.187) and calibration slope 1.139 (95% CI 0.994 to 1.283). The C-statistic was 0.829 (95% CI 0.790 to 0.868). The net benefit analysis suggested that people with a CPR score of 1 or more (risk of ulceration 6.0% or more) should be referred for treatment. CONCLUSION: The clinical prediction rule is simple, using routinely obtained data, and could help prevent foot ulcers by redirecting care to patients with scores of 1 or above. It has been validated in a community setting, and requires further validation in secondary care settings.

Item Type: Article
Additional Information: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:
Subjects: R Medicine > R Medicine (General) > R735 Medical education. Medical schools. Research
R Medicine > RA Public aspects of medicine
Divisions: Faculty of Medicine and Health Sciences > School of Primary, Community and Social Care
Related URLs:
Depositing User: Symplectic
Date Deposited: 11 Jun 2021 09:04
Last Modified: 11 Jun 2021 09:57

Actions (login required)

View Item
View Item